- Medication indicated for the treatment of
seizures associated with Lennox-Gastaut syndrome or Dravet
syndrome, two rare, severe childhood-onset epilepsies -
GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the
Group”), the world leader in the development and commercialization
of cannabinoid prescription medicines, along with its U.S.
subsidiary Greenwich Biosciences, announced today that EPIDIOLEX®
(cannabidiol) oral solution CV is now available in the U.S. for the
treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
or Dravet syndrome in patients two years of age or older.
EPIDIOLEX, which was approved by the U.S. Food and Drug
Administration (FDA) on June 25, 2018, is the first prescription
pharmaceutical formulation of highly purified, plant-derived
cannabidiol (CBD), a cannabinoid lacking the high associated with
marijuana, and the first in a new category of anti-epileptic drugs.
“We are delighted to announce that EPIDIOLEX is
now available by physician prescription as a new treatment option
for patients with LGS and Dravet syndrome, two of the most
difficult-to-treat forms of childhood-onset epilepsy,” said Justin
Gover, Chief Executive Officer of GW Pharmaceuticals. “Because
these patients have historically not responded well to available
seizure medications, there has been a dire need for new therapies
that aim to reduce the frequency and impact of seizures. We are
committed to ensuring that these patients can access this novel
cannabinoid medicine that has been thoroughly studied in clinical
trials, manufactured to assure quality and consistency, and is
eligible to be covered by insurance for appropriate patients.”
The company has introduced a comprehensive
patient support program called EPIDIOLEX Engage™, which is designed
to help patients who have been prescribed EPIDIOLEX gain access to
therapy. The program offers patient/caregiver-focused education and
resources to help lower out-of-pocket costs or provide product at
no cost for eligible patients. More information can be found at
EPIDIOLEX.com.
“EPIDIOLEX is a much-needed new treatment option
for patients with LGS, a rare and severe form of childhood-onset
epilepsy that typically persists into adulthood,” said Christina
SanInocencio, Executive Director of the Lennox-Gastaut Syndrome
Foundation. “Despite the use of multiple epilepsy treatments, the
majority of LGS patients continue to have life-long, debilitating
seizures and our community welcomes the availability of a new,
first-in-class treatment option.”
“We are very pleased that EPIDIOLEX -- the first
medication to be approved by the FDA for patients with Dravet
syndrome -- is now available,” said Mary Anne Meskis, Executive
Director of the Dravet Syndrome Foundation. “Our community has long
desired a medication specifically approved for the treatment of
seizures associated with Dravet syndrome, and the availability of
EPIDIOLEX is an important milestone for patients and caregivers
whose lives are significantly impacted by this catastrophic,
lifelong form of epilepsy.”
The EPIDIOLEX clinical development program
included three randomized, controlled Phase 3 clinical trials and
an open-label extension study. The Phase 3 studies have been
published in The New England Journal of Medicine1,[2] and Lancet3.
EPIDIOLEX added to other antiepileptic therapies significantly
reduced the frequency of drop seizures in patients with LGS and
convulsive seizures in patients with Dravet syndrome. The most
common adverse reactions that occurred in EPIDIOLEX-treated
patients were somnolence; decreased appetite; diarrhea;
transaminase elevations; fatigue, malaise, and asthenia; rash;
insomnia, sleep disorder and poor quality sleep; and infections.
The company’s development program represents the only
well-controlled clinical development program of a cannabinoid
medication leading to FDA approval for patients with LGS and Dravet
syndrome.
EPIDIOLEX was developed by GW Pharmaceuticals
and will be marketed in the U.S. by its subsidiary, Greenwich
Biosciences. For more information on EPIDIOLEX, visit
www.EPIDIOLEX.com.
About EPIDIOLEX® (cannabidiol) oral
solutionEPIDIOLEX, the first prescription, plant-derived
cannabinoid medicine in the United States and the first in a new
class of anti-epileptic medications, is a pharmaceutical
formulation of highly purified cannabidiol (CBD) now FDA approved
for the treatment of seizures associated with Lennox-Gastaut
syndrome (LGS) or Dravet syndrome in patients two years of age or
older. GW has submitted a Marketing Authorization Application (MAA)
to the European Medicines Agency (EMA) for EPIDIOLEX with an
expected decision date in the first quarter of 2019. GW has
received Orphan Drug Designation from the FDA for EPIDIOLEX for the
treatment of seizures associated with tuberous sclerosis complex
(TSC). The Company has also received Orphan Designation from the
EMA for EPIDIOLEX for the treatment of seizures associated with
LGS, Dravet syndrome, and TSC. GW is currently conducting an
additional Phase 3 clinical development program in the treatment of
seizures associated with TSC.
Important Safety Information &
Indications What is the Most Important Information
I Should Know About EPIDIOLEX?Do not take if you are
allergic to cannabidiol or any of the ingredients in
EPIDIOLEX.EPIDIOLEX may cause liver problems. Your doctor may order
blood tests to check your liver before you start taking EPIDIOLEX
and during treatment. In some cases, EPIDIOLEX treatment may need
to be stopped. Call your doctor right away if you start to have any
of these signs and symptoms of liver problems during treatment with
EPIDIOLEX:
- loss of appetite, nausea, vomiting
- fever, feeling unwell, unusual tiredness
- yellowing of the skin or the whites of the eyes (jaundice)
- itching
- unusual darkening of the urine
- right upper stomach area pain or discomfort
EPIDIOLEX may cause you to feel sleepy, which
may get better over time. Other medicines (e.g., clobazam) or
alcohol may increase sleepiness. Do not drive, operate heavy
machinery, or do other dangerous activities until you know how
EPIDIOLEX affects you.
Like other antiepileptic drugs, EPIDIOLEX may
cause suicidal thoughts or actions in a very small number of
people, about 1 in 500. Call a healthcare provider right away if
you have any signs of depression or anxiety, thoughts about suicide
or self-harm, feelings of agitation or restlessness, aggression,
irritability, or other unusual changes in behavior or mood,
especially if they are new, worse, or worry you.
Take EPIDIOLEX exactly as your healthcare
provider tells you. Do not stop taking EPIDIOLEX without first
talking to your healthcare provider. Stopping a seizure medicine
suddenly can cause serious problems.
What Else Should I Know When Taking
EPIDIOLEX?The most common side effects of EPIDIOLEX
include sleepiness, decreased appetite, diarrhea, increase in liver
enzymes, feeling very tired and weak, rash, sleep problems, and
infections. EPIDIOLEX may affect the way other medicines work, and
other medicines may affect how EPIDIOLEX works. Do not start or
stop other medicines without talking to your healthcare provider.
Tell healthcare providers about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
herbal supplements, and cannabis-based products.
EPIDIOLEX is a federally controlled substance
(CV) because it has a low potential for abuse. Keep EPIDIOLEX in a
safe place to prevent theft, misuse, or abuse.
What Additional Information Applies to
Women?If you are pregnant or plan to become pregnant,
EPIDIOLEX may harm your unborn baby. You and your healthcare
provider will have to decide if you should take EPIDIOLEX while you
are pregnant.
If you become pregnant while taking EPIDIOLEX,
talk to your healthcare provider about registering with the North
American Antiepileptic Drug Pregnancy Registry (by calling
1-888-233-2334). The purpose of this registry is to collect
information about the safety of antiepileptic medicines during
pregnancy.Because many medicines like EPIDIOLEX are passed into
breast milk, talk to your healthcare provider about the best way to
feed your baby while taking EPIDIOLEX.
What is EPIDIOLEX?EPIDIOLEX is
a prescription medicine that is used to treat seizures associated
with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years
of age and older.
It is not known if EPIDIOLEX is safe and
effective in children under 2 years of age.
Please refer to the EPIDIOLEX Medication Guide
and Instructions for Use for additional important information.
You are encouraged to report side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088. You may also contact Greenwich Biosciences at
1‑833-424-6724 (1-833-GBIOSCI).
About GW Pharmaceuticals plc and
Greenwich Biosciences, Inc.Founded in 1998, GW is a
biopharmaceutical company focused on discovering, developing and
commercializing novel therapeutics from its proprietary cannabinoid
product platform in a broad range of disease areas. GW, along with
its U.S. subsidiary Greenwich Biosciences, has received U.S. FDA
approval for EPIDIOLEX (cannabidiol) oral solution for the
treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
or Dravet syndrome in patients two years of age or older. The
Company has submitted a regulatory application in Europe for the
adjunctive treatment of seizures associated with LGS and Dravet
syndrome. The company continues to evaluate EPIDIOLEX in additional
rare epilepsy conditions and currently has an ongoing clinical
trial in tuberous sclerosis complex (TSC). GW commercialized the
world’s first plant-derived cannabinoid prescription drug, Sativex®
(nabiximols), which is approved for the treatment of spasticity due
to multiple sclerosis in numerous countries outside the United
States and for which the company is now planning a U.S. Phase 3
trial. The Company has a deep pipeline of additional cannabinoid
product candidates which includes compounds in Phase 1 and 2 trials
for epilepsy, glioblastoma, and schizophrenia. For further
information, please visit www.gwpharm.com.
Forward-looking statementsThis
news release contains forward-looking statements that reflect GW's
current expectations regarding future events, including statements
regarding financial performance, the timing of commercial launch of
EPIDIOLEX, the timing of clinical trials, the timing and outcomes
of regulatory or intellectual property decisions, the relevance of
GW products commercially available and in development, the clinical
benefits of EPIDIOLEX (cannabidiol) oral solution and the safety
profile and commercial potential of EPIDIOLEX. Forward-looking
statements involve risks and uncertainties. Actual events could
differ materially from those projected herein and depend on a
number of factors, including (inter alia), the success of GW’s
research strategies, the applicability of the discoveries made
therein, the successful and timely completion and uncertainties
related to the regulatory process, and the acceptance of Sativex,
EPIDIOLEX and other products by consumer and medical professionals.
An additional list and description of risks and uncertainties
associated with an investment in GW can be found in GW’s filings
with the U.S. Securities and Exchange Commission, including
the most recent Form 20-F filed on 4 December 2017. Existing
and prospective investors are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date hereof. GW undertakes no obligation to update or revise the
information contained in this press release, whether as a result of
new information, future events or circumstances or otherwise.
Enquiries:
GW Pharmaceuticals
plc |
|
Stephen Schultz, VP Investor Relations
(U.S.) |
917 280 2424 / 401 500 6570 |
|
|
U.S. Media
Enquiries:Sam Brown Inc. Healthcare
Communications |
|
Christy CurranMike Beyer |
615 414 8668312 961 2502 |
|
|
EU Media
Enquiries:FTI Consulting |
|
Ben AtwellAndrew Ward |
+44 (0) 3727 1000 |
|
1 Devinsky O, Cross JH, Laux L, et al. Trial of cannabidiol for
drug-resistant seizures in the Dravet syndrome. N Engl J Med
2017;376;2011-20.
2 Devinsky O, Patel AD, Cross JH, et al. Effect of Cannabidiol
on Drop Seizures in the Lennox–Gastaut Syndrome. N Engl J Med
2018;378;20:1888-97.
3 Thiele EA, Marsh ED, French JA, et al. Cannabidiol in patients
with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a
randomized, double-blind placebo-controlled phase 3 trial. Lancet
2018;391;10125:1085-1096.
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/b420c8be-627c-47b3-8248-0af55a60aa23
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